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10.7.2012 Official
Journal
of
the
European
Union L
178/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 610/2012
of 9 July 2012
amending Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the
presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of
these substances in non-target feed
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(EC) No 1831/2003 of the European Parliament and of
the Council of 22 September 2003 on additives for use
in animal nutrition ( 4 ).
Having regard to the Treaty on the Functioning of the European
Union,
(3) Maximum
residue
limits
have
been
established
for
lasalocid sodium in food of animal origin from bovine
species in the framework of Regulation (EC) No
Having regard to Council Regulation (EEC) No 315/93 of
470/2009 by Commission Implementing Regulation
8 February 1993 laying down Community procedures for
(EU) No 86/2012 of 1 February 2012 amending the
contaminants in food ( 1 ), and in particular Article 2(3) thereof,
Annex to Regulation (EU) No 37/2010 on pharmaco
logically active substances and their classification
regarding maximum residue limits in foodstuffs of
animal origin, as regards the substance lasalocid ( 5 ).
Whereas:
Therefore, it is necessary to amend the provisions as
regards lasalocid sodium.
(1) Maximum
levels
have
been
set
for
certain
coccidiostats
and histomonostats in food by Commission Regulation
(4) New
technical
information,
namely
specific
studies
on
(EC) No 124/2009 of 10 February 2009 setting
transfer ratio of maduramicin from feed into eggs from
maximum levels for the presence of coccidiostats or
laying hens has become available. These studies demon
histomonostats in food resulting from the unavoidable
strate that feed for laying hens containing maduramicin
carry-over of these substances in non-target feed ( 2 ) in
due to cross-contamination but below the maximum
order to ensure a proper functioning of the internal
level results in levels of maduramicin in eggs higher
market and to protect public health.
than the currently allowed maximum level. In accordance
with the conclusions of the EFSA opinion on cross-
contamination of non-target feedingstuffs by madurami
cin ( 6 ) and the scientific opinion on safety and efficacy of
maduramicin ammonium for chickens for fattening (
(2) The
maximum
levels
should
be
continuously
adapted
in

7 ),
order to take account of developments in scientific and
these higher levels do not result in an appreciable risk
technical knowledge and the changes of maximum
residue limits established for the specific food
( 4 ) OJ L 268, 18.10.2003, p. 29.
concerned in the framework of Regulation (EC) No
( 5 ) OJ L 30, 2.2.2012, p. 6.
(
470/2009 of the European Parliament and of the

6 ) Opinion of the Scientific Panel on Contaminants in the Food Chain
on a request from the European Commission on cross-contami
Council of 6 May 2009 laying down Community
nation of non-target feedingstuffs by maduramicin authorised for
procedures for the establishment of residue limits of
use as a feed additive, The EFSA Journal (2008) 594, 1-30,
pharmacologically active substances in foodstuffs of
Available online: http://www.efsa.europa.eu/en/efsajournal/doc/594.
animal origin (
pdf

3 ) or in the framework of Regulation
( 7 ) EFSA Panel on Additives and Products or Substances used in Animal
Feed (FEEDAP); Scientific Opinion on safety and efficacy of Cygro
( 1 ) OJ L 37, 13.2.1993, p. 1.
10G (maduramicin ammonium α) for chickens for fattening. EFSA
( 2 ) OJ L 40, 11.2.2009, p. 7.
Journal 2011;9(1):1952. [2 pp.]. doi:10.2903/j.efsa.2011.1952.
( 3 ) OJ L 152, 16.6.2009, p. 11.
Available online: www.efsa.europa.eu/efsajournal

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L 178/2
EN
Official Journal of the European Union
10.7.2012
to consumers’ health. Therefore it is appropriate to
health. Therefore it is appropriate to amend the
amend the provisions as regards maduramicin accord
provisions as regards diclazuril and nicarbazin.
ingly.
(6) Therefore,
Regulation
(EC)
No
124/2009
should
be
amended accordingly.
(5) The
conditions
of
authorisation
of
nicarbazin
and
diclazuril as feed additives have been modified by
Commission Regulation (EU) No 875/2010 of
(7) The
measures
provided
for
in
this
Regulation
are
in
5 October 2010 concerning the authorisation for 10
accordance with the opinion of the Standing
years of an additive in feedingstuffs (
Committee on the Food Chain and Animal Health,

1 ) and Commission
Regulation (EU) No 169/2011 of 23 February 2011
concerning the authorisation of diclazuril as a feed
HAS ADOPTED THIS REGULATION:
additive for guinea fowls ( 2 ) respectively. Those devel
opments require significant changes to the maximum
Article 1
levels set for nicarbazin and minor changes for diclazuril
in the Annex to Regulation (EC) No 124/2009. In
The Annex to Regulation (EC) No 124/2009 is amended in
accordance with the conclusions of the EFSA opinion
accordance with the Annex to this Regulation.
on cross-contamination of non-target feedingstuffs by
nicarbazin ( 3 ) and the scientific opinion on safety and
Article 2
efficacy of nicarbazin for chickens for fattening ( 4 ), the
proposed maximum levels for nicarbazin in food as a
This Regulation shall enter into force on the twentieth day
consequence of unavoidable carry-over in non-target
following that of its publication in the Official Journal of the
feed do not result in an appreciable risk to consumers’
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 July 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 263, 6.10.2010, p. 4.
( 2 ) OJ L 49, 24.2.2001, p. 6.
( 3 ) Opinion of the Scientific Panel on Contaminants in the Food Chain
on a request from the European Commission on cross-contami
nation of non-target feedingstuffs by nicarbazin authorised for use
as a feed additive, The EFSA Journal (2008) 690, 1-34, Available
online: http://www.efsa.europa.eu/en/efsajournal/doc/690.pdf
( 4 ) EFSA Panel on Additives and Products or Substances used in Animal
Feed (FEEDAP); Scientific Opinion on the safety and efficacy of
Koffogran (nicarbazin) as a feed additive for chickens for fattening.
EFSA Journal 2010; 8(3):1551. [40 pp.]. doi:10.2903/
j.efsa.2010.1551. Available online: www.efsa.europa.eu

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EN
10.7.2012 Official
Journal
of
the
European
Union L
178/3
ANNEX
The Annex to Regulation (EC) No 124/2009 is amended as follows:
(1) The entry No 1 concerning Lasalocid sodium is replaced by the following:
"1. Lasalocid sodium Food
of
animal
origin
from
animal
species
other than poultry and bovine:
— milk;
1
— liver; 50
— kidney; 20
— other food.
5"
(2) he entry No 6 concerning Maduramicin is replaced by the following:
"6. Maduramicin Food
of
animal
origin
from
animal
species
other than chickens for fattening and
turkeys:
— eggs; 12
— other food.
2"
(3) The entry No 10 concerning Nicarbazin is replaced by the following:
"10. Nicarbazin
Food of animal origin from animal species
(residue: 4,4'-
other than chickens for fattening:
dinitrocarbanilide (DNC))
— eggs; 300
— milk;
5
— liver; 300
— kidney; 100
— other food. 50"
(4) The entry No 11 concerning Diclazuril is replaced by the following:
"11. Diclazuril Food
of
animal
origin
from
animal
species
other than chickens for fattening, turkeys
for fattening, guinea fowl, rabbits for
fattening and breeding, ruminants and
porcine:
— eggs;
2
— liver and kidney; 40
— other food.
5"

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